FDA product code GOO: Antisera, Fluorescent, All Globulins, Salmonella Spp.
GOO is the FDA product code for antisera, fluorescent, all globulins, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel. Devices under GOO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Globulins, Salmonella Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3550 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GOO devices
openFDA lists no recalls for product code GOO.
Frequently asked questions
What is FDA product code GOO?
GOO is the FDA product code for antisera, fluorescent, all globulins, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel.
What device class is GOO?
Class II, regulation 21 CFR 866.3550. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GOO
- Run a recall and safety report across every GOO manufacturer
- Watch product code GOO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.